Cleared Traditional

K150628 - VentriPoint Medical System

K150628 is an FDA 510(k) clearance for VentriPoint Medical System, manufactured by Ventripoint, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K150628 · Ventripoint, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
72d
Days
Class 2
Risk

K150628 is an FDA 510(k) clearance for the VentriPoint Medical System. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Ventripoint, Inc. (Bellevue, US). The FDA issued a Cleared decision on May 22, 2015 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K150628

510(k) Number K150628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2015
Decision Date May 22, 2015
Days to Decision 72 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 107d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1165
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K150628.
iNSIGHT Color Doppler Ultrasound System
K150002 · Saset (Chengdu), Inc. · Jun 2015
LOGIQ e
K151028 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 2015
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
K150080 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2015
ZONARE ZS3 Diagnostic Ultrasound System
K151175 · Zonare Medical Systems, Inc. · May 2015
Terason uSmart3200T Ultrasound System
K150533 · Teratech Corp. · May 2015
S30/S40 Digital Color Doppler Ultraound System
K150045 · Sonoscape Company Limited · Apr 2015